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Taking ENVARSUS XR

Protect your kidney from rejection with once-daily ENVARSUS XR.

Once-daily dosing for all adult kidney transplant patient types

ENVARSUS XR extended-release tablets are designed to work with only one dose over 24 hours.

Do not mix other brands of tacrolimus or generic tacrolimus with ENVARSUS XR. If you have been prescribed ENVARSUS XR, make sure it is the only tacrolimus medicine you are taking.

There is no substitutable generic for ENVARSUS XR.

If you are switching to ENVARSUS XR from another tacrolimus product

Your total daily dose of ENVARSUS XR may be lower than the total daily dose you were taking of another tacrolimus product. Do not change your dose of ENVARSUS XR unless your healthcare provider tells you to do so.

How do I take ENVARSUS XR?

  • Take ENVARSUS XR exactly as your healthcare provider tells you to take it.
  • Take ENVARSUS XR once-daily tablets with fluid (preferably with water) on an empty stomach, at least 1 hour before a meal or 2 hours after a meal, at the same time each day (preferably in the morning). Decide on a time with your healthcare provider so they will know what time of day to schedule your blood tests.
  • Swallow ENVARSUS XR tablets whole. Do not chew, divide, crush, or dissolve ENVARSUS XR tablets before swallowing. If you cannot swallow ENVARSUS XR tablets whole, tell your doctor.
    • Do not crush your ENVARSUS XR once-daily extended-release tabletsDo not chew your ENVARSUS XR once-daily extended-release tablets
  • If you take too much ENVARSUS XR, call your doctor or go to the nearest hospital emergency room right away.
  • You should not eat grapefruit or drink grapefruit juice while taking ENVARSUS XR.
  • You should not drink alcohol while taking ENVARSUS XR.
  • Tell your doctor if you have any side effects that bother you or that do not go away. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.
  • You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
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You may have options for saving on ENVARSUS XR*

See Savings Options

*Subject to terms and conditions. See eligibility requirements.

ENVARSUS XR is a tablet, not a capsule

Be sure to inspect your ENVARSUS XR medicine when you receive a new prescription and before taking it. Make sure your ENVARSUS XR tablet looks like the one in the picture, with the correct dosage strength number on the dose side of the tablet and the letters “TCS” on the back side. The dosage strength number on the tablet should match the dosage strength number on your pill bottle.

Dose side*

Front side of ENVARSUS XR 0.75 mg tablet

0.75-mg Tablet

Front side of ENVARSUS XR 1 mg tablet

1-mg Tablet

Front side of ENVARSUS XR 4 mg tablet

4-mg Tablet

Back side*

Back side of ENVARSUS XR 0.75 mg tablet

0.75-mg Tablet

Back side of ENVARSUS XR 1 mg tablet

1-mg Tablet

Back side of ENVARSUS XR 4 mg tablet

4-mg Tablet

*Tablets not shown at actual size.

ENVARSUS XR is not a capsule

Your pill bottle from the pharmacy must always say ENVARSUS XR. If any of these things do not match, call your pharmacist, doctor, and/or healthcare provider right away.

*Tablets not shown at actual size.

ENVARSUS XR dosing information sheet

This resource contains important tips for taking your medication. Keep this around your house to quickly answer questions about taking ENVARSUS XR.

Download Dosing Guide (PDF)
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What if I miss a dose of ENVARSUS XR?

If you miss your dose of ENVARSUS XR, it should be taken as soon as possible, but no longer than 15 hours after missing your dose. If you do not notice the missed dose until more than 15 hours later, you should skip it and take the next dose the following morning at your regularly scheduled time.

Do not take 2 doses at the same time. Also, if you miss your dose of ENVARSUS XR, call your healthcare provider as soon as possible.

What should I share with my doctor?

Before you take ENVARSUS XR, tell your doctor if you:

  • Plan to receive any live vaccines. Ask your doctor if you are not sure if your vaccine is a live vaccine.
  • Have or have had liver, kidney, or heart problems.
  • Have any other medical conditions.
  • Are pregnant or plan to become pregnant. ENVARSUS XR may harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • Are breastfeeding or plan to breastfeed. ENVARSUS XR can pass into your breast milk. You and your doctor should decide if you will breastfeed while taking ENVARSUS XR.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, natural, herbal or nutritional supplements. ENVARSUS XR may affect the way other medicines work, and other medicines may affect how ENVARSUS XR works.

Transplant care discussion guide thumbnail

Transplant care discussion guide

This transplant care discussion guide can help you plan a conversation with your doctor and help you understand what information your doctor will want to know.

Download Discussion Guide (PDF)

Get ENVARSUS XR resources

Keeping your future in focus is easier with these helpful materials.

Get Resources

Please tell us more about you:

I am expecting a kidney transplant (or am a family member/caregiver) ▶
I am an ENVARSUS XR patient (or am a family member/caregiver) ▶
I have had a kidney transplant and am not currently on ENVARSUS XR (or am a family member/caregiver) ▶
I am a healthcare professional ▶
Other ▶

What are you interested in learning about?

General information about immunosuppression ▶
Information about ENVARSUS XR ▶
Hear a transplant patient’s story ▶
General transplant resources and education ▶
Visit “About Immunosuppression” ▶
Visit “Why ENVARSUS XR?” ▶
Visit “Resources” ▶
Visit “Resources” ▶
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IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ENVARSUS XR?

ENVARSUS XR can cause serious side effects, including:

Increased risk of cancer. People who take ENVARSUS XR have an increased risk of getting some kinds of cancer, including skin and lymph gland cancer (lymphoma).

Increased risk of infection. ENVARSUS XR is a medicine that affects your immune system. ENVARSUS XR can lower the ability of your immune system to fight infections. Serious infections can happen in people receiving ENVARSUS XR that can cause death.

Call your healthcare provider right away if you have symptoms of an infection such as:

IMPORTANT SAFETY INFORMATION

ENVARSUS XR can cause serious side effects, including:

  • Increased risk of cancer. People who take ENVARSUS XR have an increased risk of getting some kinds of cancer, including skin and lymph gland cancer (lymphoma).
  • Increased risk of infection. ENVARSUS XR is a medicine that affects your immune system. ENVARSUS XR can lower the ability of your immune system to fight infections. Serious infections can happen in people receiving ENVARSUS XR that can cause death.
    Call your healthcare provider right away if you have symptoms of an infection such as: fever, sweats, chills, cough or flu-like symptoms, muscle aches, or warm, red, or painful areas on your skin.

Do not take ENVARSUS XR if you: are allergic to tacrolimus or any of the ingredients in ENVARSUS XR.

Before you take ENVARSUS XR, tell your healthcare provider about all your medical conditions, including if you: plan to receive any live vaccines, have or have had liver, kidney or heart problems, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.

If you are able to become pregnant, you should use effective birth control before and during treatment with ENVARSUS XR. Talk to your healthcare provider about birth control methods that may be right for you. Males who have female partners that are able to become pregnant should also use effective birth control before and during treatment with ENVARSUS XR. Talk to your healthcare provider before starting treatment with ENVARSUS XR about birth control methods that may be right for you.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, natural, herbal or nutritional supplements. ENVARSUS XR may affect the way other medicines work, and other medicines may affect how ENVARSUS XR works and cause serious side effects.

Especially tell your healthcare provider if you take a seizure (anticonvulsant) medicine, medicines to treat infections (antibacterials, antivirals, or antifungals), or other medicines that prevent rejection of a transplanted organ. Do not start or stop a medicine without telling your healthcare provider first.

While taking ENVARSUS XR, avoid live vaccines, exposure to sunlight and UV light such as tanning machines, eating grapefruit or drinking grapefruit juice, and alcohol.

ENVARSUS XR may cause serious side effects, including:

  • Problems from medication errors such as graft rejection and other serious reactions. People who take ENVARSUS XR have sometimes been given the wrong medicine because some medicines have the same ingredient (tacrolimus) as ENVARSUS XR. Check your ENVARSUS XR when you get a new prescription to make sure you have received the right medicine.
  • High blood sugar (diabetes). Call your healthcare provider right away if you have frequent urination, confusion, fruity smell on your breath, increased thirst or hunger, drowsiness, nausea, vomiting or stomach pain, blurred vision, or loss of appetite.
  • Kidney problems.
  • Nervous system problems. Call your healthcare provider right away if you get any of these symptoms while taking ENVARSUS XR: confusion, numbness and tingling, vision changes, coma, headache, muscle tremors, or seizures.
  • High levels of potassium in your blood.
  • High blood pressure.
  • Changes in the electrical activity of your heart (QT prolongation).
  • Severe low blood cell count (anemia).
  • Blood clotting problems. Tell your healthcare provider right away if you have fever and bruising under the skin that may appear as red dots, with or without unexplained tiredness, confusion, yellowing of the skin or eyes, decreased urination. When taken with sirolimus or everolimus, or when you develop certain infections, the risk of developing these symptoms may increase.

The most common side effects of ENVARSUS XR in people who received a kidney transplant are diarrhea, low red blood cell count (anemia), urinary tract infection, constipation, and swelling in the arms, hands, or legs (peripheral edema).

The most common side effects of ENVARSUS XR in people who are switching from immediate-release tacrolimus to ENVARSUS XR are diarrhea and high blood creatinine.

These are not all the possible side effects of ENVARSUS XR. For more information, ask your healthcare provider or pharmacist.

Approved Uses:

  • ENVARSUS XR is a prescription medicine used with other medicines to help prevent organ rejection in people who have had a kidney transplant.
  • ENVARSUS XR is an extended-release tablet and is not the same as tacrolimus extended-release capsules, tacrolimus immediate-release capsules or tacrolimus for oral suspension. Your healthcare provider should decide what medicine is right for you.

It is not known if ENVARSUS XR is safe and effective in children.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see the accompanying Medication Guide and full Prescribing Information, including Boxed Warning (PDF).